ambr 250 high throughput perfusion New Multiparallel Bioreactor to Fast Track Intensified Cell Culture Processes

Transcription

1 ambr 250 high throughput perfusion New Multiparallel Bioreactor to Fast Track Intensified Cell Culture Processes

2 A Fully-Automated Bioreactor System For Intensified Cell Culture Process Development ambr 250 high throughout perfusion is a parallel bioreactor system for rapid development of scalable perfusion processes using ml single-use bioreactors and a fully automated liquid handling platform. The system supports the typical range of hollow fibre cell retention applications, with up to 24 fully single-use perfusion bioreactors in parallel. This step change in perfusion process development capability dramatically accelerates optimization of intensified cell culture processes leading to lower production volumes and reduced cost of goods. Productivity ambr 250 dramatically improves laboratory productivity, enabling cell culture scientists to carry out many times more perfusion culture experiments and full DoE experiments at a fraction of the cost compared with traditional perfusion-enabled benchtop bioreactors. Wide Range of Fed-Batch and Perfusion Culture Conditions Perfusion cultures can be fully optimized over a wide range of important parameters, including target cell density, crossflow rate, perfusion rate, bleed volume, bleed frequency and filter type, as well as typical culture and bioreactor process conditions such as clone, media, ph, temperature, RPM and gas flows. The ambr 250 high throughput perfusion system is also capable of operating in fed-batch mode using standard ambr 250 bioreactors. Scalability With the industry standard ambr 250 high throughput mammalian cell culture bioreactor at its core, the ambr 250 high throughput perfusion system can provide highly predictive and scalable performance for fed-batch cultures, and has equivalent potential for perfusion processes. Convenience The fully automated liquid handler carries out bioreactor sampling and reagent additions, saving hours of process support time. Fully integrated single-use perfusion bioreactors dramatically reduce setup, cleaning and turnaround time, decreasing cost per experiment and allowing high system utilization with minimal development timelines. 2 2

3 ambr 250 high throughput perfusion 3

4 ambr 250 high throughput perfusion System Combines 12 or 24 Bioreactor Stations, Integrated Perfusion Pumps, Bleed and Permeate Collection with a Fully Automated Platform ambr 250 high throughput perfusion platform Integrated liquid handler, bioreactor stations, fluid pumps and perfusion towers result in an efficient, high throughput small scale model for perfusion process development and optimization. The system also includes perfusion crossflow and permeate draw pumps, and collection systems for permeate and bleed outflows. Automated liquid handler The fully automated liquid handler carries out bioreactor sampling and liquid additions, significantly reducing manual operator interactions. Integrated analytics The liquid handler transfers samples to a range of optional integrated analyzers, enabling fully automated real-time feedback control loops based on these at-line assays. Optional analyzers: ambr analysis module; Nova Bioprofile FLEX2 ; Vi-CELL XR; Cedex HiRes. 4 4

5 Perfusion towers Perfusion towers support and control key elements of the ambr 250 single-use perfusion bioreactors such as the perfusion pump chambers, pinch valve cassette and perfusion filter. Integrated biological safety cabinet A class II biological safety cabinet designed to maintain an aseptic environment even during robot manipulation of bioreactors, significantly reducing any risk of process contamination. Permeate and bleed flow control and collection system The system includes perfusion crossflow and permeate pumps, automated bleed functions, and both permeate and bleed fluid collection sets with collection bag and tubing management features. Also includes a walk-away permeate sampling system for samples up to 10 ml. Bioreactor station array 12 or 24 bioreactor stations in parallel with full individual process control, offers convenient set-up and simplifies running of full DOE experiments. 5

6 ambr 250 high throughput perfusion Bioreactor Vessels ambr 250 high throughput single-use perfusion bioreactors are available including all components required for perfusion culture, fully assembled and irradiated. Single-use perfusion bioreactors significantly reduce staff time needed for set-up and cleaning, and enable rapid system turnaround, increasing system utilization efficiency and reducing development timelines. Fully assembled and irradiated components further reduce set-up time and minimize risk of lost experiments. Bioreactor key features Core features in ambr 250 high throughput perfusion bioreactors which are also present in standard mammalian cell culture bioreactors include: ml working volume with baffles Dual 26 mm pitched blade impeller Spot-based DO sensor Disposable ph electrode Integrated gas inlet and outlet filters Robotic compatible cap for sampling Sparger and headspace gassing options Integrated exhaust gas condenser 6

7 Pressure sensors Single-use pressure sensors connect quickly to the perfusion towers and continuously monitor pressure at the culture fluid inlet and permeate outlet, enabling online monitoring of transmembrane pressure. Cell retention filter Industry standard approach to cell retention, using a hollow fibre membrane. Options include a 0.2 µm or a 30 kda filter as standard, and the filter can also be changed by the user before or during the experiment. Bioreactor perfusion features The single-use perfusion bioreactor includes a high efficiency multi-hole sparger capable of supporting very high cell densities. Two dip tubes allow flow of culture to and from the perfusion pump and filter, plus automated bleeding and bleed-to-level functions. Perfusion pump chambers Single-use pump chambers are used to drive the exchange of culture fluid between the bioreactor and the hollow fibre filter. The pump chamber assembly includes retaining clips for the cell retention filter and snaps quickly and neatly into place on the main system perfusion tower. Pinch valve cassette The single-use pinch valve cassette slots into place on the ambr 250 deck at the base of the perfusion tower. Four pinch valves guide the flow of fluids through the perfusion tubing set and enable automated bleeding functions. 7

8 Functions ambr 250 high throughput perfusion automatically controls, feeds and samples 12 or 24 bioreactors in parallel, in either perfusion or fed-batch operating modes. Bioreactor controller Three gasses per bioreactor with mass flow sensing of the mixed gas flow: O 2 CO 2 N 2 /air Four positive displacement liquid pumps per bioreactor for high precision at low flow rates When operating with perfusion bioreactors, three pumps are available for reagent addition to the bioreactor and the fourth liquid pump is used to direct permeate flow from the perfusion filter to a collection bag For fed-batch operation using standard ambr 250 high throughput bioreactors, all four liquid pumps are available for reagent additions to the bioreactor Individual bioreactor temperature control with heating or cooling Individual impeller speed control per bioreactor Optional exhaust gas monitoring for O 2 and CO 2 Integrated CIP/SIP protocols for fluid pumps and liquid lines Perfusion tower Ergonomic easy connect design for rapid installation of single-use perfusion bioreactors including all single-use perfusion components Perfusion culture crossflow pumps for each bioreactor provide individual control of perfusion flowrates Pinch valve system controls fluid flow between the bioreactor and perfusion filter, and automatically routes bleed fluid to a collection bag Online pressure monitoring at perfusion filter inlet and permeate outlet enable monitoring of transmembrane pressure Integrated perfusion tower heaters 8 8

9 Applications ambr 250 high throughput perfusion is capable of running in either perfusion culture or fed-batch mode, depending on the type of ambr 250 high throughput bioreactors installed. The system is able to cover a wide range of applications in biopharma development, including but not limited to perfusion process operations. Perfusion process clone selection Perfusion media development Perfusion process optimization Perfusion process characterization Perfusion process scale down model development 9

10 Scalability Single-Use from Cell Line and Process Development to Production Scale Geometrical similarity of vessel design Consistent mixing and gassing strategies High performance gas transfer and mixing Reliable single-use platforms ambr 250 high throughput perfusion BIOSTAT B UniVessel SU 2L BIOSTAT STR 50 BIOSTAT STR 200 Similar Geometry and Sensors - Process development 10

11 ambr 250 high throughput perfusion BIOSTAT B UniVessel Glass 1-10 L Also scalable to multi-use technologies BIOSTAT Cplus 5-30 L BIOSTAT STR 500 BIOSTAT STR 1000 BIOSTAT STR 2000 scaling up from 0.25 L to 2000 L Production 11

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